Psychotherapy for Depression and Anxiety Disorders

(MBC Trial)

Overseen By Anita Kablinger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Acute psychosis, Intellectual disability, Neurocognitive disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychotherapy, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment Measurement-Based Care, Routine Outcome Monitoring, Evidence-Based Practice for depression and anxiety disorders?

Research shows that using Measurement-Based Care (MBC), which involves regularly collecting and using patient data to guide treatment, can improve outcomes for patients with depression and anxiety. Studies indicate that MBC helps reduce symptom deterioration and increases recovery rates by providing timely feedback to therapists, allowing them to adjust treatment plans effectively. ^{1 2 3 4 5}

Is psychotherapy for depression and anxiety generally safe for humans?

Research suggests that using feedback methods in psychotherapy can reduce negative outcomes and improve recovery rates, indicating a focus on safety and monitoring during treatment. ^{1 2 3 6 7}

How is Measurement-Based Care different from other treatments for depression and anxiety?

Measurement-Based Care (MBC) is unique because it involves regularly collecting and using patient data throughout treatment to guide clinical decisions, which helps improve treatment outcomes by identifying and addressing issues early. This approach is flexible and can be integrated into any therapy, making it adaptable to individual patient needs and enhancing the effectiveness of existing treatments. ^{1 3 5 8 9}

What is the purpose of this trial?

Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care. Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework. Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.

Research Team

Virginia O'Brien, MD

Principal Investigator

Carilion Clinic

Eligibility Criteria

This trial is for adults with Generalized Anxiety Disorder or Depression who are seeking treatment. Participants should be willing to attend weekly therapy sessions for three months and can't already be receiving measurement-based care.

Inclusion Criteria

I am seeking therapy for depression or anxiety with specific test scores.

Exclusion Criteria

Significant suicidal/homicidal risk that would need immediate intervention

I cannot complete health surveys on my own.

Currently receiving psychotherapy through another source

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly individual psychotherapy sessions for 12 sessions in total

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Measurement-Based Care

Trial Overview The study tests the effectiveness of Measurement-Based Care (MBC) in treating anxiety and depression compared to usual care. It involves a randomized control trial where participants receive either MBC, standard treatment, or are placed on a waitlist.

Participant Groups

Group I: Measurement-based care group Experimental Treatment 1 Intervention

Measurement-based care group

Group II: Treatment-as-Usual group Active Control 1 Intervention

Treatment-as-Usual group

Group III: Waitlist control group Active Control 1 Intervention

Waitlist control group

Measurement-Based Care is already approved in United States, European Union for the following indications:

Approved in United States as Measurement-Based Care for:

• Adult Behavioral Health
• Mental Health Conditions

Approved in European Union as Measurement-Based Care for:

• Behavioral Health
• Mental Health Disorders

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Findings from Research

In clinical trials, 30% of patients do not respond to psychotherapy, and up to 65% leave treatment without any benefit, highlighting the need for better monitoring of patient progress.

Using computer-assisted feedback methods can significantly improve treatment outcomes, reducing deterioration rates in at-risk patients from 21% to 13% and increasing recovery rates from 20% to 35%, with even better results when combined with problem-solving strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing Psychotherapy Outcome beyond Evidence-Based Medicine. Lambert, MJ.[2017]

Using outcome measures in psychotherapy can significantly improve treatment results, especially for patients who are likely to struggle with negative outcomes.

A meta-analysis indicates that monitoring patient feedback and providing clinicians with decision-making tools can enhance treatment effectiveness for those showing early signs of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for practice. Whipple, JL., Lambert, MJ.[2015]

Tailored implementation of measurement-based care (MBC) led to a significant increase in the completion rates of the PHQ-9 depression assessment tool over a 5-month period, suggesting that personalized support can enhance clinician engagement.

Despite improvements in PHQ-9 completion, neither the tailored nor standardized MBC implementation significantly impacted depression severity outcomes, indicating that further strategic support may be necessary to optimize treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Versus Tailored Implementation of Measurement-Based Care for Depression in Community Mental Health Clinics. Lewis, CC., Marti, CN., Scott, K., et al.[2023]

In a study involving 30 therapists working with adolescents experiencing anxiety and depression, it was found that therapists shared measurement-based care (MBC) data with youth in about 34.6% of sessions and with caregivers in 27.4% of sessions.

Therapists primarily used MBC data to inform short-term treatment decisions in 21.1% of sessions, indicating a need for better training and monitoring to enhance the use of MBC for long-term treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing measurement-based care implementation using therapist report. Casline, E., Woodard, G., Patel, ZS., et al.[2023]

Measurement-based care (MBC) is an evidence-based approach that uses client data to guide treatment, leading to improved outcomes and reduced symptom deterioration across various clinical settings.

MBC not only assesses symptoms like depression and anxiety but also evaluates functioning, life satisfaction, and treatment processes, making it a versatile framework for enhancing therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Measurement-Based Care to Enhance Any Treatment. Scott, K., Lewis, CC.[2020]

A study involving 2233 patients and 79 therapists across eight NHS Trusts found that using an outcome feedback system in psychological therapy significantly reduced symptom severity in patients at risk of poor treatment response, compared to standard treatment.

Patients receiving therapy with outcome feedback showed greater improvements in depression and anxiety scores, indicating that this low-cost technology can enhance the effectiveness of psychological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback-informed treatment versus usual psychological treatment for depression and anxiety: a multisite, open-label, cluster randomised controlled trial. Delgadillo, J., de Jong, K., Lucock, M., et al.[2019]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Recent advancements in measurement techniques can enhance evidence-based practices in psychotherapy, ensuring that treatments are effective and tailored to individual needs.

These measurement improvements also facilitate 'practice-based evidence', allowing clinicians to refine their methods and improve outcomes through ongoing evaluation and feedback in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement and psychotherapy. Evidence-based practice and practice-based evidence. Margison, FR., Barkham, M., Evans, C., et al.[2019]

Fidelity measurement in psychotherapy is evolving beyond just checking treatment efficacy to also assess how well interventions are delivered in real-world settings, which is important for consumers and payers.

Developing a single, effective, and efficient fidelity measurement tool poses challenges, but efforts are being made to create instruments that can evaluate fidelity across different practice contexts and their impact on client outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's a Bird, It's A Plane, It's … Fidelity Measurement In the Real World. Schoenwald, SK.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Maximizing Psychotherapy Outcome beyond Evidence-Based Medicine. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Outcome measures for practice. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Standardized Versus Tailored Implementation of Measurement-Based Care for Depression in Community Mental Health Clinics. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Characterizing measurement-based care implementation using therapist report. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Using Measurement-Based Care to Enhance Any Treatment. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Feedback-informed treatment versus usual psychological treatment for depression and anxiety: a multisite, open-label, cluster randomised controlled trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Measurement and psychotherapy. Evidence-based practice and practice-based evidence. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

It's a Bird, It's A Plane, It's … Fidelity Measurement In the Real World. [2021]